Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.

Gelre Hospitals

Status and phase: Completed; Phase 4

Conditions: Grade II and III Acute Lateral Ankle Ligament Injuries

Treatments: Device: Lace-up brace; Device: Tape; Device: Semi rigid brace

Study type: Interventional

Funder types: Other

Identifiers

NCT01126242

09-142

Details and patient eligibility

About

The objective of this study is to compare tape versus semi rigid support versus lace up brace treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost effectiveness.

There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the treatment of acute lateral ankle ligament injury at 6 months follow-up.

Full description

This study is designed as a single blind prospective randomized controlled trial to evaluate the difference in functional outcome after treatment with tape versus semi-rigid versus lace-up ankle support (brace) for grade II and III acute lateral ankle ligament injuries. The patients will be randomly allocated into one of the three groups. Randomization will be performed by computer. Blinding of patients is not possible, but the observer will be blinded at eight weeks and six months.

Enrollment: 182 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 18 years
• Grade II or III ankle sprains
• Presentation < 72 hours after the acute injury

Exclusion criteria

• Patients with a history of chronic instability
• Who had a fracture on X-ray investigation
• Other injuries or disabilities on the same limb
• Alcoholism, serious psychiatric and neurological illness
• Patients with bilaterally sprained ankles
• Patients with previous surgery on the lateral ankle ligaments
• Skin diseases where taping is not practicable
• Patients who are unable to give informed consent
• Patients who are unable to fill out questionnaires
• Neuromuscular disorders of the lower extremities
• Active rheumatoid arthritis
• Gait disturbances

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

182 participants in 3 patient groups

tape

Experimental group

Description:

Group I will be treated with non-elastic adhesive tape around the affected ankle, applied by the 'van Unen-technique'. This technique is an alternative for the 'Coumans- technique'. The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue. Different materials can be used alone or in combination. The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself. Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity. Taping is a treatment that involves no loss of time, requires no crutches and is not attended with any ultimate impairment of function.

Treatment:

Device: Tape

Device: Lace-up brace

Device: Semi rigid brace

Lace-up brace

Active Comparator group

Description:

The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe. The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel. Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application. The calcaneus is captured, effectively locking the heel. The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.

Treatment:

Device: Tape

Device: Lace-up brace

Device: Semi rigid brace

Semi rigid brace

Active Comparator group

Description:

A semi-rigid brace, the M-step® from Medi®, will be applied. The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression. The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle. The pads are very light and have a soft fleecy surface. Even the edges of the outer moldings are generously padded. The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.

Treatment:

Device: Tape

Device: Lace-up brace

Device: Semi rigid brace